A potent painkiller, and the drug maker’s marketing, are faulted in a woman’s death

Stratford, NJ – There was a strange waiting for Sarah Fuller when he visited his doctor for you to change medications for back and neck pain -. a saleswoman throwing a potent opioid prescription version fentanyl

The drug, called Subsys, is so powerful, and the risk of addiction and overdose so formidable that the Food and Drug Administration requires doctors to receive special training before they are allowed to prescribe. And Subsys approved only for cancer patients who suffer intense pain flares.

Fuller did not have cancer. She had been in two car accidents and has been diagnosed with painful fibromyalgia. However, your doctor “let the sales representative start talking about help with the pain,” David Fuller, who accompanied her daughter to the appointment, said STAT.

Sarah’s father, David, was present when her daughter met with Dr. Vivienne Matalon and Insys sales representative.

Just over a year after the office visit January 2015, 32-year-old Sarah Fuller was found dead in his room by her fiance. The county coroner ruled his death the result of “adverse drug effect.” A toxicology examination revealed a level of fentanyl in the blood that the experts consulted by STAT said it is lethal. There was also a small amount of the drug against anxiety Xanax in his system.

Synthetic forms of fentanyl, most of it sent illegally from China have flooded in the US and Canada in the last year, causing hundreds of overdose deaths. But the case of Sarah Fuller shows that the version of the prescription drug can also be dangerous when he prescribed “off-label” for conditions that are not approved for – doctors and have encouraged Insys Therapeutics representatives sales to do just that.

“They killed her,” Sarah’s mother, Deborah Fuller said of those involved in putting his daughter on a regimen of high doses of fentanyl, which is up to 100 times more potent morphine.

There is no indication of fentanyl use and subsequent death was other than the legal drug that was prescribed for his pain nothing, said Richard Hollawell a Marlton, NJ, the lawyer hired by the family of Sarah to investigate his death . He said the family plans legal action against both Insys Dr. Vivienne Matalon and, Cherry Hill, N.J., physician prescribing the Subsys.

phone messages and emails to public relations representative Insys and an official of the company were not returned. Matalon did not answer several messages left at his office and home.

Dominick Reuter for STAT The Cherry Hill, New Jersey, where Dr. Vivienne Matalon practices mall.

mother Sarah, Deborah, says Matalon and sales representative are responsible for the death of his daughter.

While doctors can prescribe drugs for off-label conditions, drug manufacturers promote drugs for these purposes is not allowed. Insys, based in Chandler, Ariz., Is being investigated by several federal prosecutors general and prosecutors for marketing Subsys, according to the revelations that the company has made in public presentations values. On Thursday Federal prosecutors in Connecticut charged a former sales manager Insys district, whose territory includes New Jersey, with the alleged payment of bribes to doctors for prescribed fentanyl.

Insys has already solved a case in Oregon. The attorney general did not allege Insys was “implicitly deceive patients Subsys should be used to treat migraines, neck pain, back pain and other uses not for those who Subsys is neither safe nor effective.” Subsys settled the case last year by making a payment of $ 1.1 million. It is not admitted to any inappropriate behavior.

In addition, both a sales representative Insys in Alabama and a nurse in Connecticut have pleaded guilty to federal charges related to the backlash Subsys off-label prescribing. These cases alleged that doctors and a nurse kickbacks were paid by company employees to prescribe the drug. Sales representative in Alabama a base salary of $ 40.000 was paid, but received more than $ 700,000 in commissions from 2013 to 2015 based on the volume of prescriptions written off label by doctors called for, according to court documents.

The aggressive and illegal marketing of Subsys comes as the country deals with an epidemic of opiate addiction. It other instances of illegal marketing of opiates have been blamed for helping to fuel the crisis is clear. In 2007, Purdue Pharma, the maker of OxyContin painkiller, pleaded guilty a criminal charge related to the sale of drugs and paid more than $ 600 million in fines.

“We created a system by which [drug] companies to go out and break the law, which may or may not get caught, and if they were discovered, they are just going to pay a settlement,” said Eric Campbell, professor of health policy at Harvard Medical School, who is also as an expert witness for the federal government in a case of off-label marketing ongoing. “The agreement will be paying less than what they do to these activities. It’s like parking tickets in delivery trucks.”

Sarah Fuller is not the only patient Subsys presumed to have died from taking the prescribed medication. A case filed in July in Jacksonville, Fla., Argues Carolyn Markland died in 2014, just hours after taking Subsys in the doctor’s office. She was being treated for chronic back pain.

Subsys is the only Insys sells brand name drug. In 2011, the year before it hit the market, Insys was operating at a loss without income reported. Last year, company revenues were $ 330 million and a gain of $ 58.5 million was reported dollars.

Recently, the company announced that its founder, John Kapoor, is stepping down as CEO. According to a financial presentation March, Kapoor is the largest shareholder of the company, with a stake worth just $ 600 million based on the latest closing price of the shares Insys.

Sarah’s parents describe how opioid changed their daughter.

Sarah first started using large analgesics measured after a car accident a decade ago, said his family during an interview in the modest ranch-style house where Sarah lived outside Philadelphia.

His car was wide on one side by another vehicle and suffered several herniated discs in his back and neck. Just two years earlier, his vehicle was hit from behind at a stop sign. The accident also left with spinal pain.

it was not long before she was completely dependent on drugs. She was in so many drugs in 2014, his kidneys failed, according to the father, a baker, and his mother, who worked as office manager.

His family said Sarah personality and physical condition changed after she became a chronic user of opioids. As a child, who was a standout football player. After high school, he worked for several years as an assistant in nursing homes. Often extras, shifts back-to-back hours extra money would be collected. He liked hanging out with friends.

In medicines, he was lethargic and unmotivated, his family said. She gained 100 pounds. Cuts even as far as the length of the driveway proved difficult. He spent his days in his pajamas and slippers, with the blinds closed.

A printed copy of your prescription at a local pharmacy Rite Aid, from mid-2007 and continuing until his death in March, runs 122 pages. There are 974 individual recipes listed, many of them for the supply of 30 days and some for longer. The drugs include OxyContin and Percocet analgesics, antidepressants and anxiolytics.

Sarah received its first shipment of Subsys on January 9, 2015: a box with a supply of 20 days dose of 200 micrograms of the drug, delivered by FedEx. Medicare, which covers Sarah after she was determined to be disabled after a second car accident, paid $ 5.509 for prescription, according to a ledger pharmacy billing.

The following month, the dose of Subsys Sarah tripled to 600 micrograms, and the cost doubled to Medicare. In August 2015, Sarah began receiving 30-day supply instead of 20. His last delivery was the March 22, 2016, just three days before his death. The box contained 180 doses of Subsys at a cost of $ 19,657 to Medicare.

Richard Hollawell The last box Subsys drug that gave Sarah Fuller.

During the 15 months Sarah was in Subsys, Medicare paid $ 250,544 for Subsys was prescribed, according to a billing ledger prepared by Linden Care, a Woodbury, N.Y., specialty pharmacy.

After start taking fentanyl, its need for opioids was more intense. Subsys is administered by a spray under the tongue and quickly enters the bloodstream. It is meant to be taken every four hours. Sarah would set his alarm at night to make sure she awoke to take a dose on time. If he waited more than four hours, he would begin to shake and stir. The drug also intensifies feelings of depression, his family said.

She sometimes additional dose is taken. Some months, she would run out before it reached the next installment. To get her through the days that had Subsys, Sarah would take OxyContin she was also prescribed, his mother said.

Dr. Adriane Fugh-Berman, a physician and professor at Georgetown University who helped the District of Columbia to develop training programs for opioid prescribers, said that high doses of fentanyl prescribed Fuller was likely inappropriate.

“do not work well for chronic pain,” said drug as Subsys. In the long term, daily use of high doses of fentanyl can reduce oxygen levels in the blood. The respiratory system is depressed, and Fugh-Berman said it is not uncommon for some people in large doses of opioids to die in their sleep.

Asked about the presence of drugs in Insys representative meeting with Fuller doctor, Fugh-Berman called a “new level of scandalous behavior and inappropriate.”

Hollawell, the lawyer who represents the Fuller family, said he confirmed the sales representative was at the meeting of the notes taken in the medical record of Sarah in the doctor’s office.

The amount of fentanyl circulating in the blood after his death Sarah was 15 to 20 times the therapeutic level and well above the rates considered lethal, said Dr. Lewis Nelson, chief of emergency medicine at Rutgers Medical School in New Jersey. “This is clearly a fentanyl death,” he said.

“It is quite possible that it was only this chronic drug overdose and a little,” Nelson said. “She also had too by accident or purpose.”

Subsys, Nelson said, is being “marketed far beyond its intended use.”

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